# LMA: Digitizer, Image, Radiological

- Device class: 2; regulation: 21 CFR 892.2030; FDA's rule: 510(k) exempt
- FDA decisions: 61
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1999: 4
- 2000: 5
- 2001: 3
- 2002: 3
- 2003: 2
- 2004: 1
- 2006: 1
- 2009: 1
- 2010: 2
- 2013: 3

## Most-cited predicates
- K000411: Chili Video, Chili Videopro (2000), cited by 4
- K933632: Medscan 12 (1993), cited by 3
- K993597: PLLL, Teleradpro, Model 12714/12715, VXR-12 Plus, Model 8619/9617 (1999), cited by 3
- K020243: Laserpro 16 (2002), cited by 2
- K980213: DI-2000 (1998), cited by 2
- K901423: Digital Image Scanner, Model Dis-1000 (1990), cited by 2
- K933830: Konica LD-4500 Laser Digitizer (1993), cited by 2
- K974315: Vidar VXR LS Laser Film Digitizer (1998), cited by 2
- K990066: CCD Camera, Model 9000 (1999), cited by 1
- K932760: DFS-2100 (1994), cited by 1

Source page: https://510kreport.com/product-code/LMA
Data by year (CSV): https://510kreport.com/product-code/LMA.csv